Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501189
Status:
WITHDRAWN
Last Update Posted:
2024-06-11
First Post:
2007-07-12
Brief Title:
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Sponsor:
Eisenhower Army Medical Center
Organization:
Eisenhower Army Medical Center
Study Overview
Official Title:
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Status:
WITHDRAWN
Status Verified Date:
2008-07
Last Known Status:
Enrolling by invitation
Delayed Posting:
No
If Stopped, Why?:
recruiting issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group
Research hypothesis Women with low grade cervical dysplasia on Papanicolaou Pap smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33 higher than historical controls that did not receive Gardasil vaccination
Research hypothesis Women with low grade cervical dysplasia on Papanicolaou Pap smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33 higher than historical controls that did not receive Gardasil vaccination
Detailed Description:
This study is looking for additional clinical outcomes in women who are already getting the Gardasil vaccination We are not giving the vaccination as part of the research protocol This point will be stressed to patients Their participation or non-participation will not impact their ability to receive the vaccine series Their participation only impacts whether or not we will contact them in the future and whether or not we will review their medical records
Subjects will be enrolled into the study at the time of their presentation for colposcopy in the EAMC Family Medicine Clinic Subjects will be screened for inclusion and exclusion criteria Those found eligible will be consented for enrollment by one of the study investigators Colposcopy records will also be searched for patients seen in the colposcopy clinic between the availability of Gardasil and the beginning of this study Any patients who meet enrollment criteria will be contacted by phone and invited to participate in the study These patients will be followed in the exact same way as patients enrolled upon presenting for the first time to the colposcopy clinic
Patients will be given their first vaccination at the time of their colposcopy appointment unless they have already begun the vaccine series Phone and email will be used to remind patients when they are due for their second and third vaccinations Any study subject that does not receive the their 2nd or 3rd vaccine will be considered partially vaccinated They will not be removed from the protocol however because an intention-to-treat analysis is planned
Study subjects will be followed prospectively for up to 15 months 15 months was chosen because some patients may be late getting their one-year follow ups AHLTA records and colposcopy clinic convenience files will be reviewed for each patient periodically Patients who meet criteria to return to routine annual Pap smear based on ASCCP guidelines during the next 11 to 15 months will be considered as reversion Those patients who have ASCUS HPV LGSIL or HGSIL on Pap smear at 11 to 15 months past their original Pap smear will be considered persistent Historical control subjects will also be grouped into reversion and persistent using the same criteria
Subjects will be enrolled into the study at the time of their presentation for colposcopy in the EAMC Family Medicine Clinic Subjects will be screened for inclusion and exclusion criteria Those found eligible will be consented for enrollment by one of the study investigators Colposcopy records will also be searched for patients seen in the colposcopy clinic between the availability of Gardasil and the beginning of this study Any patients who meet enrollment criteria will be contacted by phone and invited to participate in the study These patients will be followed in the exact same way as patients enrolled upon presenting for the first time to the colposcopy clinic
Patients will be given their first vaccination at the time of their colposcopy appointment unless they have already begun the vaccine series Phone and email will be used to remind patients when they are due for their second and third vaccinations Any study subject that does not receive the their 2nd or 3rd vaccine will be considered partially vaccinated They will not be removed from the protocol however because an intention-to-treat analysis is planned
Study subjects will be followed prospectively for up to 15 months 15 months was chosen because some patients may be late getting their one-year follow ups AHLTA records and colposcopy clinic convenience files will be reviewed for each patient periodically Patients who meet criteria to return to routine annual Pap smear based on ASCCP guidelines during the next 11 to 15 months will be considered as reversion Those patients who have ASCUS HPV LGSIL or HGSIL on Pap smear at 11 to 15 months past their original Pap smear will be considered persistent Historical control subjects will also be grouped into reversion and persistent using the same criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None